Operating Room Innovations ORI-SDL-LEAD

GUDID 26975424194438

Universal Lower Extremity Drape

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use

• Primary Device ID: 26975424194438
• NIH Device Record Key: 1713b749-caba-4a7f-90d9-4fc2bac9496e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Operating Room Innovations
• Version Model Number: ORI-SDL-LEAD
• Catalog Number: ORI-SDL-LEAD
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424194434 [Primary]
GS1	26975424194438 [Package]; Contains: 06975424194434; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• KKX: Drape, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [Operating Room Innovations]

• 26975424193943: Universal Upper Extremity Drape
• 26975424194438: Universal Lower Extremity Drape